- Determine the pharmacodynamic effects of sirolimus on tumor, normal skin, and normal
oral mucosa of these patients

- Correlate the pharmacodynamic effects of sirolimus with pharmacokinetics and clinical
effects.

- Correlate the Akt signaling pathway with pharmacodynamic endpoints.

- Explore pharmacokinetic-pharmacodynamic and toxicodynamic relationships of sirolimus in
these patients.

- Quantify the toxicity of sirolimus in these patients.

- Evaluate, preliminarily, the activity of sirolimus in these patients.

OUTLINE: This is a prospective, dose-escalation study.

Patients receive oral sirolimus once daily on days 1-28. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of sirolimus until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose limiting toxicity. The pharmacodynamic optimal dose is
considered the dose at which 10 patients are treated without requiring further dose
escalation.

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